Prosthetic mitral valve holders

ABSTRACT

Valve holders and introducers for delivering a prosthetic heart valve to an implant site are in various embodiments configured to facilitate insertion of prosthetic valves through small incisions or access sites on a patient&#39;s body. The valve holders can also be configured to reduce or eliminate the occurrence of suture looping or other damage to the prosthetic valve during implantation. A valve holder according to embodiments of the invention includes features that reduce or eliminate mistakes during implantation of the prosthetic valves, for example, a removable activator dial and a removable handle that prevent implantation of the valve prior to proper deployment or adjustment of the holder. An introducer is provided which can facilitate passing of a prosthetic valve between adjacent ribs of a patient. Valve holders and introducers according to the various embodiments can be used in minimally invasive procedures, such as thoracotomy procedures.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. Patent Application No.62/417,207, filed Nov. 3, 2016, the entire disclosure of which isincorporated by disclosure.

BACKGROUND Field

The present disclosure generally concerns medical devices, deploymentmechanisms, and methods for deploying such medical devices. Morespecifically, the disclosure relates to surgical replacement of nativeheart valves that have malformations and/or dysfunctions. The presentdisclosure also relates to prosthetic heart valves, and specifically,prosthetic mitral valves that can be implanted through a minimal sizedincision. Embodiments of the invention relate to holders forfacilitating the implantation of bioprosthetic replacement heart valvesat native heart valves, for example, for a mitral valve replacementprocedure. Embodiments of the invention also relate to methods of usingthe holders to facilitate implantation of prosthetic heart valves.

Description of Related Art

Referring first to FIG. 1, the human heart is generally separated intofour pumping chambers, which pump blood through the body. Each chamberis provided with its own one-way exit valve. The left atrium receivesoxygenated blood from the lungs and advances the oxygenated blood to theleft ventricle through the mitral (or bicuspid) valve. The leftventricle collects the oxygenated blood from the left atrium and pushesit through the aortic valve to the aorta, where the oxygenated blood isthen distributed to the rest of the body. Deoxygenated blood from thebody is then collected at the right atrium and advanced to the rightventricle through the tricuspid valve. The right ventricle then advancesthe deoxygenated blood through the pulmonary valve and the pulmonaryarteries to the lungs to again supply the blood with oxygen.

Each of the valves associated with the chambers of the heart are one-wayvalves that have leaflets to control the directional flow of the bloodthrough the heart and to prevent backflow of the blood into otherchambers or blood vessels that are upstream of the particular chamber.For example, as described above, the mitral valve controls the flow ofoxygenated blood from the left atrium to the left ventricle, whilepreventing blood flow back into the left atrium. The valves are eachsupported by an annulus having a dense fibrous ring attached eitherdirectly or indirectly to the atrial or ventricular muscle fibers. Whena valve become diseased or damaged, leakage or regurgitation may occur,where some of the blood travels back upstream through the diseased ordamaged valve, and the efficiency and/or general functionality of theheart may be compromised.

Various surgical techniques can be performed to repair or replace adiseased or damaged valve. In some valve replacement procedures, theleaflets of the diseased or damaged native valve are at least partiallyremoved to prepare the valve annulus for receiving the prostheticreplacement valve. FIG. 2 shows an example of one type of popularprosthetic replacement valve 1 that is a tissue-type bioprosthetic valvegenerally constructed with natural-tissue valve leaflets 2, made forexample, from porcine tissue or bovine pericardium, or from synthetic orsemisynthetic material, that are mounted on a surrounding valve stentstructure 3. The shape and structure of the leaflets 2 is supported by anumber of commissure posts 4 positioned circumferentially around thevalve stent structure 3. In these valves, a biocompatible cloth-coveredsuture or sewing ring 5 can also be provided on an inflow end of thestent structure 3 of the valve 1, to facilitate easier attachment to thenative valve annulus. Such prosthetic valves function much like naturalhuman heart valves, where the leaflets coapt against one another toeffect the one-way flow of blood.

When implanting a tissue type prosthetic valve as described above at anative valve annulus, a number of sutures may be involved in theattachment process, many of which may be pre-installed for providing atrack on which the valve is advanced to and properly positioned at theimplant site. Additional sutures may also be applied between theprosthetic valve and the heart walls after proper placement, to securelyattach or hold the valve implant in place. Meanwhile, in some cases, theprosthetic valves are implanted through small access channels using oneof various minimally invasive surgical procedures, where visibility atthe implant site may be impeded or obstructed. In addition, depending onthe direction of implantation, for example, with some mitral valvereplacement procedures, commissure posts of the stent or frame, or otherportions, of the prosthetic valve may be pointed distally and advancedon a blind side of the valve, thereby obstructing visibility of theposts or other portions during advancement and implantation.

Each of the above factors may lead to tangling of the sutures with thevalve prosthesis, most commonly with the commissure posts of the frame,since the commissure posts provide a protrusion on which the sutures caneasily loop around and tangle. This type of entanglement of sutures withprosthetic valves is referred to as “suture looping,” which specificallyrefers to instances where a suture is inadvertently wrapped around oneor more of the commissure post tips, where it can then migrate towardsand damage the leaflets or interfere with proper leaflet coaptation orother valve operation when the sutures are tightened or secured,resulting in improper valve operation. In some cases, such tangling maynot be apparent to the practitioner at the time of implantation, andwill only be revealed some time later when valve operation is observedto be improper or other complications arise in the patient, in whichcase, it may be necessary to initiate another procedure to repair orreplace the prosthetic valve.

In addition, many existing bioprosthetic valves are not amenable toimplantation through a minimal size incision, such as in thoracotomyprocedures. Such procedures can require a surgical valve and its holderto fit through incisions of approximately 15-20 mm in its narrowestdirection or dimension.

SUMMARY

Attempts have been made to resolve the issue of suture looping, some ofwhich involve holders, which hold the prosthetic valves during deliveryof the valves to the native valve annulus. In one example, a holder hasa mechanism that urges the commissure posts of the prosthetic valveradially inwardly during delivery, such that the ends of the commissureposts are pointed inwards, to reduce the possibility of sutures catchingagainst or looping around the commissure posts. After the valveprosthesis is delivered to the implant site, the holder is removedthereby releasing and expanding the commissure posts to their originalpositions. However, such holders may not be amenable to minimallyinvasive surgical techniques as the holder and valve combination mayhave a high or large profile, for example with the entire holder systempositioned outside the valve, or the holder may not pull in thecommissures enough to reduce the valve profile.

Meanwhile, Edwards Lifesciences has developed a valve holder system thatcan be used in mitral valve replacement procedures to protect the valvefrom suture looping during valve implantation. The system includesmonofilament sutures that attach to both the holder and the commissuresof the prosthetic valve, so that the sutures run over the outflow end ofthe valve between the ends of the commissures. When the holder isactuated, a central post extends distally through the prosthetic valvebetween the leaflets and pushes against the sutures that run across themiddle of the valve between the commissures, pushing the suturesdistally and causing an angled tent-like or “umbrella” effect on thesutures. The pressure on the sutures deflects the commissures slightlyinwardly, while also forming angled surfaces or tracks with the suturesthat slope outwardly from the central post to the commissure posts.These angled surfaces deflect any other sutures that might otherwise belooped over a commissure or leaflet away from the prosthetic valve.However, this system may not be very amenable to a minimally invasivesurgical approach. The system does not pull in the commissures enough toreduce the valve profile, and the central post of the holder adds to theoverall height of the valve once deployed, hindering minimally invasivesurgical procedures.

In addition to the above, many of the newer holder designs alsoincorporate many additional parts that must be assembled by thepractitioner or other end user, which may also lead to additionalcomplications. Some holders incorporate various mechanisms and lineconnections, such that a number of additional steps must be taken by thepractitioner to operate the holders correctly. Many of these holdershave proven to be too complicated and/or prone to user error. Forexample, some holders may allow valves to be implanted without requiringthat its mechanism be activated or deployed prior to delivery, forexample, holders that allow delivery without deploying its mechanism tourge the commissure posts radially inward prior to insertion.Consequently, when practitioners use these holders improperly, suturelooping still commonly occurs, while the implant process may also befurther complicated by issues arising from user error. Further, someholders may require the practitioner to manually adjust the tighteningof the holder to the prosthetic valves. Tightening too little can makethe holder ineffective to prevent suture looping, while over-tighteningcan risk breaking one or more sutures of the system or damaging thevalve.

Accordingly, a new replacement valve holder includes built-inmistake-proofing to ensure the anti-suture looping mechanism is engaged.In some embodiments, the new replacement valve holder can be designed toenable surgeons to implant the valve through minimal incisions, such asin thoracotomy procedures.

In one example, to fit through a minimal size incision, such as throughan about 15-20 mm incision, a valve and holder combination can becollapsible in at least one direction. However, such holders and valvesmay not include a mechanism to actively collapse the valve into thereduced size configuration for delivery. Accordingly, an introduceraccording to other embodiments of the invention can be used withcollapsible surgical valves and/or holders to introduce them into narrowsurgical incisions, such as thoracotomies.

Features of the present disclosure provide for new holder systems andmethods of using the holder systems, which reduce or eliminate theoccurrence of suture looping or other damage to the prosthetic valvesduring implantation, for example, for mitral valve replacement usingminimally invasive procedures or other procedures. Operation of theholders is also simplified, whereby the valves are prevented from beingimplanted prior to deployment of the holders, for example, via aremovable activator dial, thereby reducing or eliminating mistakescaused by user error. According to embodiments, the dial cannot beremoved until the system is activated, and while in place, the activatorprevents the valve from being implanted. In some embodiments, the holderincludes a removable handle that cannot be connected to the system untilthe removable activator dial is removed. The holders also provide forintegrated alignment features or other safety features, such thatover-deployment or under-deployment of the holders is prevented.

According to embodiments of the invention, holders for prosthetic valvedelivery reduce or eliminate occurrences of suture looping and/or otherdamage to the valves when the valves are implanted, while the mechanismsfor deploying these features are integrated into the holders in a waythat reduces or eliminates mistakes in use and deployment.

In some embodiments, a mitral valve holder and handle system is providedthat uses a ratchet mechanism to pull in the commissures of the valvetowards the center of the valve, thereby eliminating the risk of suturelooping. The holder has mistake-proofing features that prevent thephysician from implanting the valve without engaging the system. In someembodiments, by flattening the profile of the valve, the holder systemcan allow implantation of the valve through a small or minimal incision.According to some embodiments, an introducer is provided to aid inimplanting replacement valves through a minimal size incision, forexample, by aiding in collapsing or otherwise reducing the profile ofthe valve and/or valve holder. The introducer can be used, for example,with mitral and/or aortic surgical valves. In some embodiments, such anintroducer can be relatively short and only long enough to pass thevalve past a patient's ribs. In other embodiments, the introducer can berelatively long and, for example, act as an atrial retractor, forming achannel all the way to the implant site in the case of a mitral valve.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and advantages of the invention will become apparentfrom the description of embodiments using the accompanying drawings. Inthe drawings:

FIG. 1 shows a schematic cross-sectional view of a human heart;

FIG. 2 shows a schematic perspective view of an example of a prostheticvalve that can be used with embodiments of the invention;

FIG. 3 shows an exploded perspective view of a valve holder for aprosthetic mitral valve according to a first embodiment of theinvention;

FIG. 4 shows a perspective view of the valve holder of FIG. 3 in anassembled state;

FIG. 5 shows a cross-sectional view of the valve holder of FIGS. 3 and4;

FIGS. 6A and 6B respectively show top and bottom views of a body of thevalve holder of FIGS. 3 to 5;

FIG. 7 shows a perspective view of a rotor of the valve holder of FIGS.3 to 5;

FIG. 8 shows a cross-sectional view of the rotor of FIG. 7 attached tothe body of FIGS. 6A and 6B;

FIG. 9 shows a perspective view of an activator of the valve holder ofFIGS. 3 to 5;

FIG. 10 shows a top view of a delivery mount of the valve holder ofFIGS. 3 to 5;

FIG. 11 shows a perspective view of the delivery mount of FIG. 10attached to a handle;

FIG. 12 shows a perspective view of the valve holder of FIGS. 3 to 5 ina deployed configuration with the activator removed and the deliverymount pivoted for insertion with sutures;

FIG. 13A shows a side view of the valve holder of FIGS. 3 to 5 with aprosthetic valve in an unattached state;

FIG. 13B shows a side view of the valve holder of FIGS. 3 to 5 in anun-deployed configuration with a replacement valve attached thereto;

FIG. 13C shows a side view of the valve holder of FIGS. 3 to 5 in adeployed configuration with a replacement valve attached thereto;

FIG. 13D shows a side view of the valve holder of FIGS. 3 to 5 in adeployed configuration with the activator removed and the delivery mountpivoted for insertion, and with a replacement valve attached thereto;

FIG. 14 shows an exploded perspective view of a valve holder for aprosthetic mitral valve according to a second embodiment of theinvention;

FIG. 15 shows a perspective view of the valve holder of FIG. 14 in anassembled state;

FIG. 16 shows a cross-sectional view of the valve holder of FIGS. 14 and15;

FIG. 17 shows a perspective view of the valve holder of FIGS. 14 to 16in an assembled state with sutures;

FIG. 18A shows an exploded perspective view of a valve holder for aprosthetic mitral valve according to a third embodiment of theinvention;

FIG. 18B shows a perspective view of an underside of a guide of thevalve holder of FIG. 18A;

FIG. 18C shows a perspective view of an activator dial of the valveholder of FIG. 18A;

FIG. 19 shows a perspective view of the valve holder of FIG. 18A in anassembled state;

FIG. 20 shows a cross-sectional view of the valve holder of FIGS. 18Aand 19;

FIG. 21 shows a perspective view of the valve holder of FIGS. 18A to 20in an assembled state with sutures;

FIG. 22 shows a perspective view of the valve holder of FIGS. 18A to 21in an assembled state with a latch removed;

FIG. 23 shows a perspective view of a handle that can be used with thevalve holder of FIGS. 18A to 22;

FIG. 24 shows a perspective view of the handle of FIG. 23 attached tothe valve holder of FIGS. 18A to 22;

FIG. 25 shows a perspective view of an introducer for use with a valveholder; and

FIG. 26 shows a front view of the introducer of FIG. 25.

DETAILED DESCRIPTION

Disclosed herein are various tools, such as valve holders andintroducers, for assisting in the delivery and implantation ofprosthetic heart valves, such as mitral heart valves, at an implantsite. Disclosed are also methods for preparing the prosthetic heartvalves for such procedures. Embodiments of the valve holders reduceoccurrences of various complications that may arise during implantation,while remaining simple for end users to use. By providing these improvedvalve holders, damage to the prosthetic valves during surgicalprocedures can be reduced, and additional costs for extended oradditional procedures and/or replacement valves can be avoided.

The valve holders disclosed herein are particularly useful for avoidingsuture looping and other valve damage during advancement of theprosthetic valves to the implant sites, as well as during final suturingof the valves at the native valve annulus. In many existing mitral valvereplacement procedures, commissure posts of the prosthetic valve pointdistally away from practitioners, and in the direction of valveadvancement and may be more prone to suture looping or other entangling.For such procedures, valve holders according to embodiments of theinvention can urge the commissure posts radially inwards toward a centerof the valve to reduce or eliminate suture looping. The presentedembodiments can also include features that prevent valve implantationuntil the valve holders are in the activated or deployed positions. Theholders can also include alignment features that prevent over-deploymentor under-deployment. In this fashion, the holders provide ease of usewhile minimizing or reducing user errors.

The disclosed mitral valve holder and handle system is specificallydesigned to address shortcomings in previous valve holders. Thedisclosed system prevents clinicians from forgetting to deploy thesystem by means of a mistake-proof dial. The dial itself cannot beremoved until the system is activated, and while the dial is in place,the dial prevents the valve from being implanted by: (1) physicallymaking the system too bulky for implantation; (2) preventing the valvefrom being rotated or pivoted relative to the handle to a properorientation for implantation; and (3) obstructing access to the sewingring, thereby making placing sutures in the valve difficult.

FIGS. 3 to 5 show views of a valve holder 100 according to a firstembodiment. FIG. 3 shows an exploded perspective view of the valveholder 100, FIG. 4 shows a perspective view of the valve holder 100 inan assembled state, and FIG. 5 shows a cross-sectional view of the valveholder 100 in the assembled state.

The valve holder 100 includes a body 102, a rotor 104, a swivelingdelivery mount 106, a delivery handle 108, and an activator dial 110. Asdescribed in more detail below, a prosthetic heart valve can be attachedto the body 102. The rotor 104 is positioned in a bore of the body 102and is adjustable using the dial 110 to deploy or activate the valveholder 100 to adjust the prosthetic valve to a delivery position orconfiguration. The delivery mount 106, coupled to the delivery handle108, is attached to the body 102 for delivering the valve to the implantsite. The prosthetic valve can include a Nitinol wireform exhibiting alarge amount of flexibility.

The body 102 of the valve holder 100 is shown in greater detail in FIGS.6A and 6B. The body 102 includes a generally circular-shaped central hub112 with a plurality of arms 114 extending from the central hub 112. Thearms 114 serve as routing points for connecting commissure posts of theprosthetic valve to the valve holder 100 via sutures or other flexiblematerial. In the embodiment shown, the body 102 includes three arms 114,but can include more or fewer arms 114 in other embodiments depending onthe prosthetic valve the valve holder is intended to hold. The number ofarms 114 generally corresponds to the number of commissure posts on theprosthetic valve. When three arms 114 are included in the body 102, thearms 114 can extend from the body 102 at approximately 120 degreesrelative to each other.

Each of the arms 114 includes one or more through holes or bores 117 forrouting the sutures. As will be described more fully below, the suturesare used to deploy or activate the valve holder 100 and place the valvein a delivery position where the commissure posts are urged radiallyinwards toward a center of the valve to reduce or eliminate suturelooping. The through holes 117 extend transverse through the arms 114.The through holes 117 route the sutures across the top of the arms 114to a region below the arms 114 where the sutures can connect to tips ofthe commissure posts, for example, by passing the sutures over and/orthrough other portions of the valve. Multiple through holes 117 can beprovided. Through holes 117 a, closer to the central hub 112, can beused to fasten or tie off an end of the sutures to the body 102, and tofacilitate easier release of the valve from the valve holder 100.Through holes 117 b, located nearer free ends of the arms 114, are usedto route and position the sutures for connection to the commissureposts. In one embodiment, the sutures are routed through the arms 114 asfollows. An end of the suture is fastened to the through hole 117 a ofthe arms 114, for example, via a knot. The suture is then routed acrossa length of the arms 114 towards and through hole 117 b. The free endsof the sutures are then in position to connect to the commissure postsof the valve. In other embodiments, a different number of through holes117 can be provided, and in some embodiments, only one through hole 117is provided on each arm 114. In addition, a surface of the arms 114includes a recess or slot 123. The sutures extend across the recesses123 when extended between holes 117 a and 117 b, such that there is aclearance underneath the sutures in the region of the recesses 123 toprovide space for cutting the sutures. Cutting the sutures at the regionof the recess 123 will release the valve from the valve holder 102. Ifthe valve is in the delivery position, cutting the sutures will alsoallow the commissures to spring back to a normal or unbiased geometry byreleasing the commissure posts. Each of the sutures connected to thearms 114 are cut to release the valve.

In order to have a good angle between the commissures of the valve, thesutures, and the holder 100 for transmitting force to pull in thecommissures, the sutures are routed from the tip of a commissure to theopposite cusp area of the body 102.

In the body 102, a bore 116 is provided with an abutting surface 116 afor receiving the rotor 104 therein. The abutting surface 116 a servesas a stop for the rotor 104. The bore 116 extends into a bottom portion118 of the body 102 that is circular-shaped and can have a smaller outerdiameter than the central hub 112, for example, to provide clearance fora connected prosthetic valve. A through hole or bore 119 is positionedin the bottom portion 118 for coupling the rotor 104 to the body 102.The bottom portion 118 additionally includes through holes or bores 120for routing the sutures from the tips of the commissure posts to insideof the bore 116 for attachment to the rotor 104. The number of throughholes 120 generally corresponds to the number of arms 114. The throughholes 120 can be co-linear with a direction of extension of the arms 114and can be located along a periphery of the bottom portion 118. Thethrough holes 120 can be located opposite to the position of the arms114.

As shown in FIGS. 3 to 5, when the body 102 is connected to the deliverymount 106 and delivery handle 108, one of the arms 114 a is aligned withthe handle 108, for example co-linear with the handle 108, and two ofthe arms 114 b extend away from the handle 108. In a region adjacent abase of the arm 114 a, the central hub 112 includes upwardly extendingprojections 121. The projections 121 have a profile that matches aninner profile of the handle 108. On a side of the body 102 opposite tothe arm 114 a, a tab 122 is provided for connecting the delivery mount106 to the body 102. Meanwhile, the arms 114 b can be shaped to provideclearance for the delivery mount 106 and the delivery handle 108.Similarly, an outer surface of the central hub 112 in a region adjacentthe arms 114 b can also have cutouts or other surface features toprovide clearance for the delivery mount 106 and the delivery handle108.

While the central hub 112 and the bottom portion 118 are depicted asgenerally circular portions in the described embodiment, these portionscan have different cross-sectional shapes in other embodiments.

FIG. 7 shows a perspective view of the rotor 104 of the valve holder100, and FIG. 8 shows a cross-sectional view of the rotor 104 attachedto the body 102. The rotor 104 is configured to be positioned inside ofthe bore 116 of the body 102 and is rotatable with respect to the body102. The rotor 104 is connectable to the sutures for adjusting theprosthetic valve to the delivery position using the activator dial 110,as described further below. The rotor 104 includes a central portion 124with a longitudinal axis and a plurality of outwardly extending flexiblearms 125. The flexible arms 125 are resilient such that the arms can bedeflected inwards towards the central portion 124 and then released,causing the arms 125 to spring back into a relaxed shape when no longerdeflected.

The rotor 104 is configured to be received in the bore 116 of the body102. The rotor 104 includes a coupling mount 128 on the central portion124 to rotatably couple to the hole 119 in the bottom portion 118 of thebody 102. When coupled, the connection between the coupling mount 128and the hole 119 permits rotation, but restricts translational movementof the rotor 104 relative to the body 102. The coupling mount 128 isdepicted as a protrusion that extends to a position below the body 102,and may be snap fit into hole 119. The coupling mount in otherembodiments can be designed in any number of different ways, so long asthe connection permits rotation and restricts translation of the rotor104 relative to the body 102. In some embodiments, the rotor 104 may bea monolithic part. In other embodiments, the rotor 104 may includeseparate components to connect to the body 102, such as snap rings,pins, and/or nuts or other fasteners. The separate components may bepositioned inside the body 102, for example, placed in a slot in thebottom portion 118 of the body 102 (not illustrated). The separatecomponents may additionally or alternatively be positioned outside ofthe body 102, for example, surrounding a portion of the coupling mount128. Meanwhile, in other embodiments, the coupling mount 128 can, forexample, have the form of a hole, which rotatably connects to aprotrusion in the bottom portion 118 of the body 102. In otherembodiments, the delivery mount 106 and/or the sutures secure the rotorwithin the body.

As shown in FIG. 8, end portions of the arms 125 have an engagementportion 126 in the form of teeth or pawls to engage a correspondingengagement portion 127 of an inner surface of the central hub 112, inthe form of a plurality of notches or grooves. The teeth 126 of therotor 104 engage the notches 127 of the body 102 to provide a one-wayratcheting mechanism that allows the rotor 104 to rotate in onedirection relative to the body 102. The teeth 126 can have an asymmetricshape, such as a triangular shape, and the notches 127 can have acorresponding asymmetric cut out, such as a triangular cut-out, thatpermits the rotor 104 to rotate in only one direction relative to theorientation in FIG. 8 (e.g., clockwise as illustrated), but thatprevents the rotor 104 from moving in a counter or opposite direction(e.g., counter-clockwise as illustrated). When the rotor 104 is rotated,the teeth 126 slide along an angular surface of the notches 127 suchthat the flexible arms 125 are compressed inwards and the teeth 126disengage from their currently engaged notches 127. When the rotor 104is rotated sufficiently that the teeth 126 approach subsequent notches127, the resilient flexible arms 125 spring back into their originalshape and engage the subsequent notches 127. Due to the shape of theteeth 126 and the notches 127, the rotor 104 is prevented from rotatingin an opposite direction and back into the previously engaged notches127. The one-way ratcheting mechanism provides ease of use and preventsmisuse of the rotor during operation. Meanwhile, while the engagementportions 126, 127 in the disclosed embodiments are depicted as having atriangular shape, the engagement portions 126, 127 in other embodimentscan be designed in any number of different ways, so long as theconnections allow for one-way rotational movement or pivoting of therotor 104 relative to the body 102. Further, in some embodiments, theengagement portions of the arms 125 of the rotor 104 can have the formof notches or grooves and the engagement portions of the body 102 canhave the form of teeth or pawls with a shape that corresponds to theengagement portions of the arms.

Further, the rotor 104 includes a central opening 129 for connection tothe activator dial 110, as described in more detail below. The rotor 104additionally includes one or more holes 130 projecting through asidewall of the rotor 104 and into the central opening 129. The holes130 provide attachment points for connecting end regions of the suturesto the rotor 104. After the sutures are routed through holes 120 in thebottom portion 118 of the body 102 as described above, end portions ofthe sutures can be connected to the rotor 104 via the holes 130. Whenthe sutures are connected to the rotor 104, rotation of the rotor 104will create tension in the suture lines and further cause the sutures tobe pulled in the direction of the moving rotor 104. Because the suturesare connected to the commissure posts of the prosthetic valve, thispulling force activates or deploys the valve holder 100 to adjust theprosthetic value to a collapsed or delivery position by transferring theforce onto the commissure posts of the prosthetic valve. The commissureposts are thereby radially urged inwards toward a center of theprosthetic valve.

FIG. 9 shows a perspective view of the activator dial 110 of the valveholder 100. The dial 110 is used by an operator or user to rotate therotor 104 and adjust the valve holder 100 to the deployed configuration.The activator dial 110 can be assembled with the valve holder 100 priorto use in a surgical procedure in an operating room. In one embodiment,for example, the activator dial 110 can be preassembled with the valveholder 100 during an assembly process by the manufacturer of the valveholder 100. Such an assembly step prior to use in surgical procedurescan be done in order to aid in proper usage of the valve holder 100 andreduce the risk of inadvertent user errors.

The dial 110 includes a central shaft 131 having a central axis, and anenlarged gripping portion 132 extending therefrom. The central shaft 131is sized and configured to be received in the central opening 129 of therotor 104. The central shaft or stem 131 includes alignment keyways 133in the shape of longitudinally extending slots or recesses for couplingto the rotor 104. The rotor 104 includes corresponding alignment keys134 in the shape of longitudinally extending protrusions positionedinside the central opening 129 to mate to alignment keys 133 of theactivator dial 110. The mating of the alignment features 133, 134enables the rotor 104 to rotate together with the dial 110 when thegripping portion 132 of the activator dial 110 is turned. In variousembodiments, the dial 110 can be turned either manually (for example, bythe hands of an operator) or automatically via a motor or other means.Meanwhile, while three mating alignment features 133, 134 arerespectively shown, the number of mating alignment features 133, 134 canbe different in various embodiments. In one embodiment, for example, asingle mating alignment feature 133, 134 can be used.

FIGS. 10 to 11 show views of the delivery mount 106 and delivery handle108 of the holder 100. The delivery mount 106 and handle 108 are used todeliver the valve to the implant site and place the valve into a properconfiguration for implantation. The delivery mount 106 is configured tobe positioned on an upper surface of the body 102 (e.g., against centralhub 112) and has a generally circular shape that corresponds to theshape of the body 102. On an outer edge of the delivery mount 106opposite to the handle 108, the delivery mount includes one or more tabs135 configured to be aligned with tab 122 of the body 102. The tabs 122,135 are used to connect the delivery mount 106 to the body 102 via asingle suture or other connector. To connect the tabs 122, 135 by asingle suture, the tabs 122, 135 can include aligned through holes orbores to route the suture. By using a single suture to connect thedelivery mount 106 to the body 102, the delivery mount 106 and handle108 can be quickly and easily removed from the body 102.

The delivery mount 106 and handle 108 are used to move the holder 100between a first configuration for delivery to the implant site, and asecond configuration for final implantation. In the first configuration,the handle 108 extends away from the body 102 in a direction oppositethe tabs 122 (FIG. 6A), 135, such that the holder 100 and coupled valvehave a low profile for insertion into the body. For example, in thisfirst configuration, the holder 100 and coupled valve can have a slimcross-sectional profile that allows the assembly to be inserted past apatient's ribs. In the second configuration, the delivery mount 106,while coupled to the body 102, is rotated or swiveled relative to thehandle 108 such that the handle 108 extends away from the prostheticvalve, for example in a direction that is substantially coaxial orparallel to a central axis of the prosthetic valve. In this secondconfiguration, the prosthetic valve is in a configuration to beimplanted in a heart of a human body (see, e.g., FIGS. 12 and 13D).

To rotate between the first and second configurations, the deliverymount 106 is rotatably coupled to the delivery handle 108 via fasteners139 (FIG. 3). The delivery mount 106 can rotate relative to the handle108 along an axis that extends between the fasteners 139. To swivel thedelivery mount 106 relative to the handle 108, the holder 100 includes apivoting connector or clevis 138 connected to an upper surface of thedelivery mount 106 on a side opposite to the handle 108. The pivotingconnector 138 is connected to one end of a flexible tension cable, andthe other end of the flexible tension cable is connected to a slide orrotation mechanism located on a grip of the handle 108 (not shown). Therotation of the valve relative to the handle 108 can therefore becontrolled with the slide located on the handle 108 grip. The slide orrotation mechanism may include a thumb wheel or a lever. The slide orrotation mechanism can be actuated to place tension onto the tensioncable, thereby pulling or pushing the pivoting connector 138 androtating the delivery mount 106 and the connected valve from the firstconfiguration to the second configuration. Meanwhile, as shown in FIG.4, when the activator dial 110 is connected to the valve holder 100, thedial 110 blocks the delivery mount 106 and handle 108 from entering intothe second configuration. As such, the dial 110 acts as a stop thatprevents the holder 100 from moving into the second configuration untilthe holder 100 has been deployed by the dial 110 to adjust the valve tothe collapsed or delivery position and the dial 110 has been removedfrom the holder 100. Safety of procedures using the holder 100 isthereby enhanced, helping to reduce or eliminate misuse of the holder100 during operation.

The delivery mount 106 additionally includes two alignment keyways 136a, 136 b for use with the dial 110. The alignment keyways 136 a, 136 bprovide ease of use and prevent misuse of the holder 100 duringdeployment. The alignment keyways 136 a, 136 b provide alignment for theactivator dial 110 and act as stops that limit rotation of the dial 110and the rotor 104 relative to body 102. To accomplish this, thealignment keyways 136 a, 136 b are sized and configured to receive a keyor protrusion 137 (FIG. 9) of the activator dial 110 therethrough whenthe dial 110 is coupled to the rotor 104. More specifically, the key 137is positioned on the central shaft or stem 131 of the activator dial 110to interact with the keyways 136 a, 136 b of the mount 106. Whenpositioning the central shaft 131 of the activator dial 110 in thecentral opening 129 of the rotor 104, the key 137 must be placed inkeyway 136 a in order to fully seat the activator dial 110 and to allowthe activator dial 110 to rotate. In use, the rotor 104 can only berotated in one direction, for example, the clockwise direction, asdescribed above.

As described above, the activator dial 110 can be preassembled with thevalve holder 100 prior to use in surgical procedures. To accomplishthis, the central shaft 131 of the dial 110 is inserted into the rotor104 with key 137 of the dial 110 inserted into keyway 136 a of thedelivery mount 106. The dial 110 and rotor 104 are then rotated relativeto the body 102 such that teeth 126 and notches 127 become engaged, thuslocking the dial 110 into the valve holder 100. In this configuration,the dial 110 is preassembled with the valve holder 100 for later use insurgical procedures. Because the engagement of the teeth 126 and notches127 provide a one-way ratcheting mechanism, the activator dial 110cannot be rotated counter-clockwise to be removed from through keyway136. The engagement of the teeth 126 and notches 127 may be heard orfelt by a “click” between the mating components as the rotor 104 isrotated. The teeth 126 and notches 127 can be identified as beingengaged when the dial 110 and rotor 104 are rotated by at least one“click.”

In use, the key 137 is inserted in keyway 136 a, either before or duringsurgical procedures. Following insertion of the key 137 into keyway 136,the dial 110 can be rotated clockwise, during surgical procedures, untilthe key 137 is lined up with keyway 136 b, at which point no furtherrotation is possible and the dial 110 can be removed. The key 137 andkeyway 136 b do not align until the dial 110 is rotated to the point offully engaging the system. At the position of keyway 136 b, theactivator dial 110 cannot be rotated counter-clockwise by virtue of theone-way ratcheting mechanism of the rotor 104 and body 102. Further,when the key 137 is inserted in keyway 136 a, the activator dial 110also cannot be rotated in the counter-clockwise direction. Lastly, aportion of the delivery mount 106 between the keyways 136 a, 136 b canbe slightly thickened to form an additional stop for the key 137 toprevent over-rotation of the dial 110. Accordingly, the keyways 136 a,136 b limit the amount of rotation of the activator dial 110 to lessthan one full turn.

The keyways 136 a, 136 b enhance the safety of the holder 100 byeliminating over-tightening or under-tightening of the valve. Safety ofprocedures using the holder 100 is enhanced because the keyways 136, 136b can only be used in one way. Safety is also enhanced because the dial110 can be preassembled with the holder 100 prior to use in surgicalprocedures. Meanwhile, once the dial 110 is assembled with the holder100, the activator dial 110 can only be removed from the holder 100 whenthe key 137 reaches keyway 136 b, requiring adjustment of the holder 100into the second configuration before the dial can be removed.

When the activator dial 110 is removed, the holder 100 can have a lowprofile for implantation through minimally invasive incisions. In oneembodiment, the height of the holder with an attached valve is betweenabout 12-20 mm when the holder 100 is in a deployed position and thecommissures of the valve are pulled down and radially inward. In someembodiments, the valve and holder combination may have a height of lessthan or equal to about 14 mm, so that the assembly would easily fitbetween most patient's ribs without spreading the ribs. This can beimportant, as spreading the ribs can result in more painful recovery forthe patient. By comparison, the height of typical valves when deployedis about 27 mm or greater, not including the holder. In addition, apivot point of the holder 100 to adjust the holder 100 into the secondconfiguration may be only between about 0 to 2 mm above an inflow edgeof the valve. In one embodiment, the pivot point may be only about 1.27mm above the inflow edge of the valve. Further, most of the ratchetmechanism of the holder 100 sits within the boundaries of the valveitself.

A length of the handle 108 may be selected or optimized for use inminimally invasive procedures, such as thoracotomy procedures. Thehandle 108 may be made out of a malleable material, such as aluminum orNitinol.

FIG. 12 shows a perspective view of the valve holder 100 with thedelivery mount 106 in the second configuration. A single suture canconnect the body 102 to the delivery mount 106 and handle 108 via thetabs 122, 135. Once the valve is parachuted or otherwise advanced to thenative valve annulus, the handle 108 can be removed after cutting thissingle suture, which quickly releases the body 102 from the mount 106and handle 108. The body 102 stays attached to the valve at this point,and the mechanism that pulls in the commissures remains activated.

FIGS. 13A to 13D show steps of using the holder 100 according to oneembodiment. FIG. 13A shows a side view of the holder 100 and aprosthetic replacement valve to be implanted. The valve has not yet beencoupled to the holder 100 and the activator dial 110 is also uncoupledfrom the holder 100. In this configuration, the valve can be attached tothe holder 100 via three sutures that connect the commissure posts ofthe valve to the body 102 and the rotor 104. As described above, one endof each of the sutures is connected to respective arms 114 of the body102 and passed through respective ones of the commissure posts. Oppositeends of each of the sutures are routed through respective holes 120 ofthe body 102 and holes 130 in the rotor 104. When initially connected,the holder 100 is in an undeployed state and the commissure posts of thevalve are in an expanded or unbiased position, as shown in FIG. 13B.

In the state shown in FIG. 13B, the activator dial 110 is coupled to theholder 100 to adjust the configuration of the holder 100. To couple thedial 110 to the holder 100, the central shaft 131 of the activator dial110 is placed inside the central opening 129 of the rotor 104 with key137 of the dial 110 aligned and inserted through keyway 136 a of thedelivery mount 106. Proper use of the dial 110 is facilitated by thekeyways 136 a, 136 b which minimize or prevent misuse of the holder 100.For example, the keyways 136 a, 136 b enable the dial 110 to bepreassembled with the holder 100 prior to use in surgical procedures, asdescribed above. In another example, should the dial 110 with the key137 be aligned and inserted into keyway 136 b, instead of keyway 136 a,the activator dial 110 will not rotate due to the one-way ratchetingmechanism of the body 102 and the rotor 104.

From the configuration shown in FIG. 13B, the activator dial 110 canthen be rotated in the clockwise direction, for example, for almost onefull rotation until the key 137 is aligned with keyway 136 b. As theactivator dial 110 is rotated, the holder 100 is moved into a deployedstate whereby the commissure posts of the valve are pulled down andinwards towards the center of the holder 100, as shown in FIG. 13C. Inthis state, the valve is ready for insertion into a body, but theactivator dial 110 remains connected to the holder 100 and preventsinsertion of the valve into a small or minimally invasive incision dueto the dial's 110 large size. While the activator dial 110 is connected,the dial 110 also prevents the handle 108 from being rotated to move theholder 100 into the second configuration for final implantation.

From the configuration shown in FIG. 13C, the activator dial 110 canthen be removed from the holder 100 when key 137 is aligned with keyway136 b. Once the activator dial 110 is removed, the low profile of thecombined valve and holder 100 allow the assembly to be inserted into apatent and moved past a patient's ribs. Once past the patient's ribs,the slide or rotation mechanism on the handle 108 can be actuated torotate or pivot the holder 100 from the first configuration to thesecond configuration.

FIG. 13D shows the holder 100 in the second configuration, with anoutflow end of the valve facing away from the handle 108. In thisconfiguration, the assembly is in position and ready to be implanted ata native heart valve of a patient. In a later step during use of theholder 100, the operator can remove the delivery mount 106 and handle108 from the holder 100 by cutting or untying the suture that connectstabs 122 and 135. In yet a later step during use of the holder 100, theoperator can remove the valve from the holder 100 by cutting or untyingthe three sutures that connect to commissure posts to the holder 100.The three sutures may be cut in the region of the recesses 123 of thearms 114 of the body 102.

FIGS. 14 to 16 show views of a valve holder 200 according to anotherembodiment. FIG. 14 shows an exploded perspective view of the valveholder 200, FIG. 15 shows a perspective view of the valve holder 200 inan assembled state, and FIG. 16 shows a cross-sectional view of thevalve holder 200 in the assembled state. Similar to the firstembodiment, the valve holder 200 of the second embodiment includes abody 202, a rotor 204, a delivery mount 206, a delivery handle 208, andan activator dial 210. The valve holder 200 of the second embodimentdiffers from the valve holder of the first embodiment in the design ofthe body 202, the delivery mount 206, and also in the connection of thevalve to the body 102.

The body 202 of this embodiment does not include the arms 114 of thefirst body, which were used for suture routing. Instead, the body 202 isshaped as a round or circular member with a suture mount 212 located ata periphery of the body 202 on a side opposite to the handle 208. Thesuture mount 212 is used as a single point to release the valve from theholder 200. For example, in embodiments where three sutures are used toattach to the commissure posts on the prosthetic valve (see FIG. 17),each of the sutures is routed through the suture mount 212. Similar tothe first embodiment, the rotor 204 can be rotated by the activator dial210 to deploy the prosthetic valve and cause the commissure posts to beurged down and radially inwards toward a center of the prosthetic valve.

In addition, in one embodiment, a single suture line can be used toconnect the prosthetic valve to the holder 200 to simplify release ofthe valve. In such an embodiment, one end of the suture is connected tothe rotor 204 via one or more holes 214 that extend through a sidewallof the rotor 204 and into a central opening 216 of the rotor 204. Thesuture is then routed from the hole 214, through a first commissurepost, and then over the suture mount 212 of the body 202. The suture isthen routed through a second commissure post and is again looped aroundthe suture mount 212. Finally, the suture is routed through a thirdcommissure post and again back to the suture mount 212, and is then tiedoff at the suture mount 212. When finished, the single suture connectsall three commissure posts to the suture mount 212 and also to the rotor204.

Meanwhile, the delivery mount 206 of the second embodiment differs fromthe first embodiment by the inclusion of a guard 218. The guard 218 islocated at a periphery of the delivery mount 206 at a side opposite tothe handle 208. The guard 218 is used to connect the delivery mount 206to the body 202. The body 202 includes two through holes 220 (FIG. 15)that extend vertically through the body 202. When the body 202 anddelivery mount 206 are connected, the through holes 220 of the body 202are adjacent to the guard 218. A single suture can be used to connectthe body 202 to the delivery mount 206 via holes 220 and the guard 218.To that end, the guard 218 includes notches 222 for ease of routing thesingle suture. This suture can be cut or untied to quickly release thebody 202 from the mount 206 and handle 208.

Further, the guard 218 provides an additional safety feature againstinadvertent or premature release of the valve from the holder 200. Whenthe delivery mount 206 is coupled to the holder 200, the guard 218 isaligned with the suture mount 212 of the body 202, and is positionedover an upper surface of the suture mount 212 to cover the suture mount212. The guard 218 blocks access to the suture connecting the valve tothe holder 200, to prevent or make difficult any inadvertent orunintended cutting or breaking of the suture that would cause the holder200 to be released from the valve while the delivery mount 206 remainscoupled to the holder 200. Therefore, while the delivery mount 206 isconnected to the body 202, a connected valve is restricted from beingprematurely or inadvertently removed. When the delivery mount 206 isremoved, the suture mount 212 is revealed and the suture can then be cutor untied to release the valve.

Assembly of the holder 200 according to one embodiment is as follows.First, the rotor 204 is received in the body 202 similar to the firstembodiment. Next, one or more sutures are used to connect the holder 200to the prosthetic valve. One end of the one or more sutures is connectedto the rotor 204, and may be connected to a hole 214 extending throughthe sidewall of the rotor 204, as described above. The other end of theone or more sutures is routed through the commissure posts of the valveand connected to the suture mount 212 of the body 202. Next, thedelivery mount 206 and handle 208 are coupled to the body 202. Thedelivery mount 206 is connected to the body 202 on a side opposite tothe valve. The delivery mount 206 is positioned such that fasteners 224and portions 226, 228 of the delivery mount 206 and handle 208,respectively, are received in slots 230 in the body 202. The deliverymount 206 is then coupled to the body 202 using one or more sutures viaholes 220 in the body and the guard 218. When all of the describedfeatures are assembled, the valve is in position to be deployed usingthe activator dial 210, similarly as discussed with respect to the firstembodiment. Additionally, once the activator dial 210 is removed, aslide or rotation mechanism on the handle 208 can be actuated to rotatethe valve from a first configuration for insertion into a patient andinto a second configuration for final implantation, also similarly asdescribed with respect to the first embodiment. In other embodiments,the assembly sequence can be varied to achieve the same or similarassembled combinations.

FIGS. 18A to 20 show views of a valve holder 300 according to a thirdembodiment. FIG. 18A shows an exploded perspective view of the valveholder 300, FIG. 18B shows a perspective view of an underside of a guide306 of the valve holder 300, FIG. 18C shows a perspective view of anactivator dial 310 of the valve holder 300, FIG. 19 shows a perspectiveview of the valve holder 300 in an assembled state, and FIG. 20 shows across-sectional view of the valve holder 300 in the assembled state.

The valve holder 300 of the third embodiment allows the use of aninexpensive, reusable handle system, with a mitral valve holder that isactivated or deployed to reduce or eliminate the occurrence of suturelooping. As in the first and second embodiments, the valve holder 300 ofthe third embodiment includes integrated alignment features or othersafety features, such that over-deployment or under-deployment of thevalve holder 300 is prevented or avoided. The valve holder 300 of thethird embodiment differs from the valve holders 100, 200 of the firstand second embodiments, for example, in that the third embodimentremoves the swiveling functions of the delivery mounts 106, 206 anddelivery handles 108, 208 of the first and second embodiments. Instead,the valve holder 300 can be attached and implanted via an inexpensive,reusable handle. Thereby, the valve holder 300 of the third embodimentcan require fewer components than the first and second embodiments, asimpler assembly of the valve holder 300, and may provide a lower costsystem.

The valve holder 300 of the third embodiment includes a body 302, arotor 304, a guide 306, a delivery latch 308, and an activator oractivator dial 310. Similar to the first and second embodiments, aprosthetic heart valve can be attached to the body 302 of the valveholder 300 of the third embodiment (see FIGS. 21, 22, and 24). The rotor304 is positioned in a bore of the body 302 and is adjustable using thedial 310 to deploy or activate the valve holder 300 for adjusting theprosthetic valve to a delivery position, as in the first and secondembodiments. In the delivery position, the commissure posts of theprosthetic valve are urged downward and radially inwards toward a centerof the valve to reduce or eliminate suture looping. As described infurther detail below, the valve holder 300 includes an alignment keyway336 for limiting rotation of the dial 310 and the rotor 304 relative tothe body 302. This is to prevent over-deployment or under-deployment ofthe valve. The alignment keyway 336 is provided on a guide 306, which isattached to the body 302. Unlike the first and second embodiments, thethird embodiment does not include a swiveling delivery mount coupled toa delivery handle. Instead, the delivery latch 308 is attached to thebody 302, and is used to connect to a delivery handle 305 (see FIGS. 23and 24).

The body 302 and rotor 304 of the third embodiment can be the samecomponents or similar components as the body 202 and rotor 204 of thesecond embodiment. In particular, the body 302 and rotor 304 can beattached to the prosthetic valve using the same suture routing asdescribed above with respect to the first and second embodiments. Thatis, three sutures can be used to attach the valve holder 300 to thecommissure posts on the prosthetic valve as described above, and in someembodiments, a single suture line can be used to connect the prostheticvalve to the holder 300, also as described above. In addition, the body302 includes a suture mount 312, which is the same or similar to thesuture mount 212 of the second embodiment, and can provide a singleaccess point to release the valve from the holder.

Meanwhile, the body 302, rotor 304, and dial 310 include the one-wayratcheting mechanism of the first and second embodiments to move theholder 300 into the deployed state by pulling the commissures of theprosthetic valve down and radially inward towards the center of thevalve, and the description thereof will not be repeated, As describedabove with respect to the first and second embodiments, a central shaftor stem 331 of the dial 310 can be inserted into and connected to therotor 304, such that turning the dial 310 rotates the rotor 304. Also asdescribed above with respect to the first and second embodiments, holesin the rotor 304 (e.g., in sidewalls of the rotor 304) can provideattachment points for connecting and routing sutures. In someembodiments, the central shaft 331 is hollow and has an internal cavity(see FIG. 20), for example, to provide clearance for the suturesconnected to inside of the rotor 304. The central shaft 331 can beinserted into the rotor 304 such that a bottom surface of the centralshaft 331 is positioned adjacent or near a correspondence horizontalsurface of the rotor 304. In such embodiments, a lower portion of thecentral shaft 331 can include openings (e.g., notches) 309 to aid withsuture routing (see FIG. 20). The openings 309 can extend through thewalls of the central shaft 331 and exposes the holes in the rotor 304used to connect to the sutures.

Similar to the delivery mounts 106, 206 of the first and secondembodiments, the guide 306 of the third embodiment provides ease of useand prevents misuse of the holder 300 during deployment. As shown inFIG. 20, the guide 306 is positioned above the rotor 304 such that thedial 310 must pass through a central opening 316 of the guide 306 beforethe dial 310 can be connected to the rotor 304. The guide 306 includes akeyway 336 and a wall 344, which provide alignment for the activatordial 310 via a key or protrusion 337 on the central shaft 331 of thedial 310 (see FIGS. 18A and 18C). The keyway 336 and the wall 344 of theguide 306 act as a stop that limits rotation of the dial 310 and therotor 304 relative to body 302.

As shown in FIG. 18C., in some embodiments, the key 337 of the dial 310may be positioned on a flexible arm 339 of the central shaft 331. Theflexible arm 339 may be spaced apart from the remainder of the centralshaft 331 by gaps 341 on either side of the flexible arm 339 such thatthe flexible arm 339 is movable (e.g., bendable) relative to theremainder of the central shaft 331. The flexible arm 339 may be bentinwards relative to the remainder of the central shaft 331 and towards acavity 343 of the dial 310. The flexible arm 339 may be resilient suchthat the flexible arm 339 may be bent by the application of a force andreturn to its original shape when the force is removed. The flexible arm339 may be connected to an upper portion 345 of the dial 310.

In some embodiments, the dial 310 may be used in conjunction with theguide 306 to place the valve holder 300 in a deployed configuration asfollows. The central shaft 331 of the dial 310 may be inserted into thecentral opening 316 of the guide 306 in an orientation such that the key337 of the dial 310 is aligned with (e.g., rotationally aligned with) aportion of the guide 306. In some embodiments, the key 337 may berotationally aligned with a marker 342 of the guide 306. The key 337 ofthe dial 310 extends from dial 310 with a length that is greater thanthe diameter of the central opening 316 of the guide 306. As such, uponinsertion of the central shaft 331 into the guide 306, a lower surface337 b of the key 337 will contact an upper surface 332 of the guide 306.Due to the flexibility of the flexible arm 339 of the dial 310, contactbetween the key 337 of the dial 310 and the upper surface 332 of theguide 306 causes the flexible arm 339 to bend inwards into the cavity343 such that the key 337 may pass through the central opening of theguide 306. The lower surface 337 b of the key 337 has an oblique orslanted shape (e.g., via a chamfer or fillet) relative to the uppersurface 332 of the guide 306 to facilitate inward bending of theflexible arm 339 (see FIG. 18C). Once the key 337 passes the centralopening 316 of the guide 306, the flexible arm 339 returns to itsoriginal (e.g., unbent) shape. An upper surface 337 a of the key 337 hasa flat shape that matches an underside surface 346 of the guide 306 toprevent or hinder the flexible arm 339 from bending once the key 337passes the central opening 316 of the guide 306 (see FIG. 18C). This isto retain the dial 310 in the guide 306 and prevent inadvertent orunintended removal of the dial 310 before deployment of the valve holder300 is complete.

Once the key 337 passes the central opening 316 of the guide 306 and thedial 310 is connected to the rotor 304, the dial 310 may be rotated tocause the rotor 304 to rotate and deploy the valve, similarly describedabove with respect to the previous embodiments. The rotor 304 has aone-way ratcheting mechanism such that the dial 310 may only be rotatedin one direction (e.g., clockwise relative to the orientation shown inFIGS. 18A and 19), and the dial 310 is prevented from being rotating inan opposite direction. The underside of the guide 306 has a channel orgroove 348 to facilitate rotation of the dial 310 relative to guide 306,which provides clearance for the key 337 of the dial 310 duringrotation. The channel 348 has a shape that encompasses a partialcircumference of the guide 306. That is, the channel 348 has acircumference that is less than 360 degrees such that the activator dial310 is restricted to less than one full rotation in use. The guide 306additional has a wall 344 to prevent over-deployment or over-tighteningof the valve. The wall 334 acts as a stop against the key 337 to limitfurther rotation of the dial 310 when the key 337 is rotated in thechannel 348. The wall 344 is adjacent the keyway 336 of the guide 306such that when the dial 310 has been fully rotated in the channel 348,the dial 310 may be removed by removing the key 337 upwards through thekeyway 336. The keyway 336 is sized to permit the key 337 of the dial310 to fit therethrough. Upon removal of the dial 310, the valve holder300 is in the fully deployed configuration. In addition, the keyway 336and the one-way ratcheting mechanism prevent under-deployment of thevalve. The dial 310 is prevented or hindered from being removed from theguide 306 until the key 337 is aligned with the keyway 336.

As shown in FIG. 20, the guide 306 is positioned in a bore 311 of thebody 302, and is coaxial with a central axis of the body 302 and therotor 304. In some embodiments, the guide 306 is positioned in the body302 such that an upper surface 322 of the guide 306 is flush with orrecessed relative to an upper surface 324 of the body 302. The guide 306includes a generally circular-shaped central hub 314 with the centralopening 316, and a plurality of arms 317 extending from the central hub314. In some embodiments, the central hub 314 may have other shapes(e.g., triangular, square, rectangular, irregularly shaped, or otherwiseshaped). As described above, the central opening 316 of the guide 306 issized to permit the central shaft 331 of the activator dial to extendtherethrough in order for the dial 310 to engage with the rotor 304 fordeployment of the valve holder 300. In some embodiments, the guide 306may include the marker 342 for identifying a connection orientation ofthe guide 306 relative to the body 302. The marker 342 may be alignedwith one of the arms 317.

The arms 317 of the guide 306 are used to connect the guide 306 to thebody 302. In the embodiment shown in FIG. 20, the guide 306 includesthree arms 317, but can include more or fewer arms 317 in otherembodiments. When three arms 317 are included in the guide 306, the arms317 can extend from the guide 306 at approximately 120 degrees relativeto each other. The body 302 includes a plurality of openings or channels320 to connect the guide 306 to the body 302. The openings 320 of thebody 302 can extend through the body 302 from the upper surface of thebody 302 to a lower surface 326 of the body 302. The arms 317 of theguide 306 contain connection elements 328 that are designed to connectto the body 302 when the arms 317 are inserted into the openings 320 ofthe body 302. In some embodiments, the connection elements 328 of theguide 306 may include flat surfaces that mate with (e.g., abut) thelower surface 326 of the body 302. The arms 317 of the guide 306 may beresilient. In some embodiments, the arms 317 may connect to the body 302via a snap fit, press fit, or other connection. In some embodiments, theguide 306 may be connected to the body 302 via a threaded engagement,and/or via pins or other fasteners or connection types.

The delivery latch 308 is positioned on the guide 306, as shown in FIG.20, and is coaxial with the central axis of the body 302, the rotor 304,and the guide 306. In some embodiments, the delivery latch 308 ispositioned on the upper surface 322 of the guide 306.

The delivery latch 308 includes a central opening 330 that extendstherethrough. The central opening 330 is designed to receive the dial310, which as described above, is used to deploy or activate the valveholder 300 to adjust the prosthetic valve to the delivery position. Inparticular, the delivery latch 308 enables the stem of 331 of the dial310 to be inserted into the latch 308, inserted into the guide 306, andconnected to the rotor 304 for deploying the valve holder 300. When thedial 310 is removed from the latch 308, the central opening 330 of thedelivery latch 308 is designed to receive and connect to the deliveryhandle 305 for implantation of the prosthetic valve. However, while thedial 310 is positioned inside the delivery latch 308, the dial 310prevents the handle 305 from being inserted into delivery latch 308.Thereby, the dial 310 acts as a feature that prevents implantation untilthe dial 310 has been removed from the valve holder 300. Safety ofprocedures using the valve holder 300 are thereby enhanced, helping toreduce or eliminate misuse of the holder 300 during operation.

The central opening 330 of the delivery latch 308 is sized to permit thestem 331 and key 337 of the dial 310 to be inserted into the opening 330and pass through the latch 308, so that the stem 331 engages the ratchetmechanism of the body 302 and rotor 304, and so that the key 337 of thedial 310 engages the guide 306 as described above. In some embodiments,the central opening 330 includes a generally circular cross section. Insome embodiments, the central opening 330 includes a generally circularcross section with a notch 332 for guiding the key 337 of the dial 310through the delivery latch 308 at a particular rotational orientation,as shown in FIGS. 18, 20, and 21.

The central opening 330 of the delivery latch 308 includes an engagementportion 334 to mate with a corresponding engagement feature 338 of thehandle 305. The handle 305 is configured to be inserted into the centralopening 330 of the latch 308 and removably coupled to the latch 308 forimplantation. In some embodiments, the engagement portion 334 of thelatch 308 and the engagement feature 338 of the handle 305 includemating threads 334 a, 338 a. In such an embodiment, the opening 330 ofthe latch 308 can include a non-threaded lead-in portion 340 locatedadjacent the threads 334 a. When the handle 305 is inserted into thecentral opening 330 of the latch 308, the threads 338 a of the handle305 may first reach the non-threaded portion 340 of the latch 308 beforereaching the threads 334 a of the latch 308. The non-threaded portion340 helps prevent potential cross threading and particle generation byensuring axial alignment of the threads 338 a of the handle 305 andthreads 334 a of the latch 308. The threads 338 a of the handle 305 areprovided on an end or tip of the handle 305. In some embodiments, thethreads 338 a are made of a single piece and are crimped onto a nitinolshaft of the handle 305.

In some embodiments, an inner diameter between the threads 334 a in thecentral opening 330 is sized such that the stem 331 and key 337 of thedial can pass therethrough. In embodiments containing the notch 332 inthe central opening 330, the notch 332 can extend through the threads334 a of the latch 308 for guiding the key 337 of the dial 310 throughthe delivery latch 308. In such embodiments, the inner diameter betweenthe threads 334 a in the central opening 330 may be sized such that onlythe stem 331 of the dial 310 can pass through the threads, but not thekey 337 (i.e., the key 337 fits through the notch 332 instead of theinner diameter between the threads 334 a). This allows for a diameter ofthe stem 331 of the dial 310 to be smaller and the threads 338 a of thehandle 305 to be smaller. In some embodiments, the mating threads 334 a,338 a have, for example, from a #10-24 thread to a 7/16″-14 thread, oran M4×0.7 thread to an M12×1.75 thread.

Meanwhile, the delivery latch 308 of the third embodiment includes aguard 318 that is the same or similar to the guard 218 of the deliverymount 206 of the second embodiment. The guard 318 is located at aperiphery of the delivery latch 308. Opposite to the guard areprotrusions 319 for engaging horizontal openings 321 on the body 302.The guard 318 and protrusions 319 are used to connect the delivery latch308 to the body 302. The guard 318 allows a single suture to connect thedelivery latch 308 to the body 302, as described above for the deliverymount 206. Further, the guard 318 provides an additional safety featureagainst inadvertent or premature release of the valve from the holder300. When the delivery latch 308 is coupled to the holder 300, the guard318 is aligned with the suture mount 312 of the body 302, and ispositioned over and covers the suture mount 312, thereby preventing orreducing inadvertent or unintended cutting or breaking of the suturesconnecting the holder 300 to the valve. When the delivery latch 308 isremoved, the suture mount 312 is revealed and the suture or suturesconnecting the valve holder 300 to the valve can then be cut or untiedto release the valve.

Assembly of the holder 300 according to some embodiments is as follows.First, the rotor 304 is received in the body 302 similar to the secondembodiment. Next, the guide 306 is coupled to the body 302 in positionover the rotor 304. In particular, the arms 317 of the guide 306 areinserted into the openings 320 of the body 302. Next, one or moresutures are used to connect the holder 300 to the prosthetic valve, asdescribed above with respect to the second embodiment. In someembodiments, the holder 300 may be connected to the prosthetic valvebefore the guide 306 is coupled to the body 302. Next the delivery latch308 is coupled to the body 302 in position over the guide 306. Thedelivery latch 308 is coupled to the body 302 using one or more sutures,the guard 318, and the protrusions 319. When all of the describedfeatures are assembled, the valve holder 300 is in position to bedeployed using the activator dial 310, similarly as discussed withrespect to the first and second embodiments. In particular, theactivator dial 310 is inserted into the central opening 330 of the latch308, passed through the latch 308 and the guide 306, and connected tothe rotor 304. The activator dial 308 is rotated to deploy the valveholder 300, and is then removed from the holder 300. Once the activatordial 310 is removed, the handle 305 can be inserted into and connectedto the latch 308 for insertion and implantation of the attached valveinto a patient. In other embodiments, the assembly sequence can bevaried to achieve the same or similar assembled combinations.

Meanwhile, various different features from the different embodimentsdiscussed above can also be combined into a single modified valveholder. In addition, various other modifications or alternativeconfigurations can also be made to the valve holder according to theabove described embodiments.

The presented embodiments also include an introducer which aids indelivering valve holders in minimally invasive surgical procedures. Theintroducer can be used with collapsible surgical valves to introduce thevalves into a narrow surgical incision, such as a thoracotomy. Theintroducer can be used, for example, for delivering a prosthetic mitralvalve to the mitral position. The introducer has a funnel-like shape forpassing a collapsible heart valve from outside the body to inside thebody through a narrow opening, such as the space between two ribs. Inthoracotomy procedures, an incision is introduced into the chest cavitythrough the chest wall. In intercostal approaches, the incision is madebetween adjacent ribs to minimize cuts through bone, nerves, and muscle.In a typical thoracotomy procedure, the distance between the ribs,without spreading the ribs, is from about 15 mm to about 20 mm Parallelto the ribs, the incision can be longer as needed, for example,approximately 45 mm or greater. Collapsible valve holders can have asmall size that is particularly suited to fit in the small gap betweenthe ribs in thoracotomy procedures.

FIGS. 25 to 26 show views of an introducer 400 for introducing a valveand holder into a human body according to another embodiment. Theintroducer 400 provides a simple alternative approach for implantingcollapsible heart valves connected to flexible holders through a minimalsize incision, such as in a thoracotomy procedure. Due to the small gapbetween human ribs, the introducer 400 is used as an aid for insertingvalves mounted on alternative flexible holders past the ribs and intothe chest cavity during a thoracotomy or other minimally invasiveprocedures.

The introducer 400 has a hollow, funnel-like shape for receivingflexible holders with mounted valves, with a central axis of the valvespointed in a direction of insertion, for example, with an outflow end ofthe valve pointed or directed towards the introducer 400. The introducer400 has a first, proximal end 402, and a second, distal end 404. Thedistal end 404 of the introducer faces towards the incision, while theproximal end 402 faces away from the incision and towards the operatorof the holder. The proximal end 402 has a circular cross-sectional shapecorresponding to the circular shape of the prosthetic heart valves. Inuse, the proximal end 402 is located outside of the incision. In oneembodiment, the cross-section of the proximal end 402 is 45 mm indiameter. The distal end 404 has an oval cross-sectional shapecorresponding to a size and shape of a surgical opening between ribs ina thoracotomy procedure. In one embodiment, the major diameter of thecross section of the distal end 404 is about 45 mm in diameter and theminor diameter of the cross section is from about 15 mm to about 20 mmin diameter. Between the proximal and distal ends 402, 404, theintroducer 400 includes a smooth transition zone or region 406connecting the ends 402, 404. The transition region 406 may have asmooth, continuous inner profile between the ends 402, 404, which issubstantially free from corners.

The introducer 400 can be made very inexpensively as a disposable itemthat is supplied with a valve. For example, the introducer 400 can bemade of or include polypropylene, or any other suitable material havinga low coefficient of friction. The introducer 400 can be a molded part.Meanwhile, the valve to be implanted can be made of a Nitinol wireformband exhibiting a large degree of elasticity. In one embodiment, thevalve exhibits superelastic properties.

In use, the introducer 400 is first introduced into an incision in thechest cavity with the distal end 404 positioned between two ribs. Thevalve, connected to a flexible holder, is inserted into the proximal end402 of the introducer 400. The valve is then pushed towards the smaller,distal end 404 of the introducer 400, where the valve elasticallydeforms to squeeze through the smaller cross-sectional shape. The valvecan take on the oval shape of the introducer or another generallycollapsed shape as it is pushed through. Once the valve clears thedistal end 404 of the introducer 400, the valve regains its undeformedshape (e.g., a circular shape). In this way, the deformation of thevalve and holder is passive, being imposed or dictated by the shape ofthe introducer rather than by a mechanism on the holder itself. Theadvantage of this configuration is that the holder can be a veryinexpensive molded component.

In one embodiment, a length of the introducer 400 is sufficient tointroduce the valve into an internal surface of the chest wall past therib cage. In such an embodiment, a length of the introducer from theproximal end 402 to the distal end 404 may be up to about 40 mm long. Inother embodiments, a length of the introducer can be made longer. In oneembodiment, the distal end 404 could be extended many more centimetersso that it would extend, for example, into the left atrium of the heart,for a mitral valve replacement, to act as an atrial retractor.Meanwhile, the proximal end 402 of the introducer 400 can remainpositioned outside of the incision in the chest cavity. This wouldprovide a tunnel from the outside of the body all the way to the site ofimplantation at the annulus.

In alternative embodiments, the introducer 400 can include variousadditional features, for example, a slit in a wall of the introducer 400can be provided to give clearance for sutures passing through a side ofthe introducer during surgical procedures. In addition, lighting, suchas light emitting diodes (“LEDs”) and/or at least one optical fiber, canbe added to the introducer, along with a power supply, such asbatteries, to power the lighting. LED lighting can be inexpensivelyadded to the introducer with a built-in battery. The lighting can beparticularly useful with the extended version of the introducer. Thelighting can provide excellent illumination at the site of implantationand reduce the need for additional external lighting.

For purposes of this description, certain aspects, advantages, and novelfeatures of the embodiments of this disclosure are described herein. Thedisclosed methods, apparatus, and systems should not be construed asbeing limiting in any way. Instead, the present disclosure is directedtoward all novel and nonobvious features and aspects of the variousdisclosed embodiments, alone and in various combinations andsub-combinations with one another. The methods, apparatus, and systemsare not limited to any specific aspect or feature or combinationthereof, nor do the disclosed embodiments require that any one or morespecific advantages be present or problems be solved.

Although the operations of some of the disclosed embodiments aredescribed in a particular, sequential order for convenient presentation,it should be understood that this manner of description encompassesrearrangement, unless a particular ordering is required by specificlanguage set forth below. For example, operations described sequentiallycan in some cases be rearranged or performed concurrently. Moreover, forthe sake of simplicity, the attached figures may not show the variousways in which the disclosed methods can be used in conjunction withother methods. Additionally, the description sometimes uses terms like“provide” or “achieve” to describe the disclosed methods. These termsare high-level abstractions of the actual operations that are performed.The actual operations that correspond to these terms can vary dependingon the particular implementation and are readily discernible by one ofordinary skill in the art.

In view of the many possible embodiments to which the principles of thedisclosure can be applied, it should be recognized that the illustratedembodiments are only preferred examples and should not be taken aslimiting the scope of the disclosure. Rather, the scope of thedisclosure is defined by the following claims.

What is claimed is:
 1. A valve holder for holding and implanting aprosthetic heart valve comprising a frame and a plurality of flexibleleaflets, the valve holder comprising: a body for holding the prostheticheart valve, the body having a top surface, a bottom surface, and acentral axis extending between the top and bottom surfaces; a rotorpositioned in the body, the rotor rotatable around the central axis ofthe body to adjust the prosthetic heart valve to a delivery position;and an activator separable from and connectable to the rotor forrotating the rotor around the central axis of the body; wherein a stoplimits the rotation of the activator to less than one full turn aroundthe central axis of the body, wherein an engagement portion isconfigured to engage a removable handle with the valve holder forimplanting the prosthetic heart valve, and wherein when the activator isconnected to the rotor, the activator remains disengaged from theengagement portion and prevents the removable handle from engaging withthe engagement portion and connecting with to the valve holder.
 2. Thevalve holder of claim 1, wherein the rotor is rotatable around thecentral axis of the body in a first direction and not rotatable in asecond direction opposite the first direction.
 3. The valve holder ofclaim 1, further comprising a guide coupled to the body, and a latchcoupled to the body, wherein the stop is located on the guide, andwherein the engagement portion is located on the latch for connecting tothe removable handle.
 4. The valve holder of claim 3, wherein the topsurface of the body is coupled to the guide and to the latch, andwherein the bottom surface of the body is attachable to the prostheticheart valve.
 5. The valve holder of claim 3, wherein the guide and thelatch define openings to permit the activator to access the rotor, andwherein the guide is located between the latch and the rotor.
 6. Thevalve holder of claim 5 wherein the opening in the latch is connectableto the removable handle.
 7. The valve holder of claim 6, wherein theopening of the latch comprises a threaded portion that forms theengagement portion configured to engage a threaded portion of theremovable handle.
 8. The valve holder of claim 7, wherein the threadedportion of the removable handle is at a tip of the handle.
 9. The valveholder of claim 3, wherein the activator comprises a key and the guidecomprises a keyway having a shape corresponding to a shape of the key,the keyway permitting the key to pass therethrough when disconnectingthe activator from the rotor.
 10. The valve holder of claim 9, whereinthe activator is only disconnectable from the rotor when the key isrotationally aligned with the keyway.
 11. The valve holder of claim 10,wherein the rotor is rotatable around the central axis of the body in afirst direction and not rotatable in a second direction opposite thefirst direction, and wherein when the key of the activator is alignedwith the keyway, the activator is prevented from rotating in the firstdirection.
 12. The valve holder of claim 1, further comprising a latchhaving an opening in which the engagement portion is formed and throughwhich the activator is insertable to connect the activator to the rotor.13. The valve holder of claim 1, further comprising the removablehandle.
 14. The valve holder of claim 13, wherein the engagement portioncomprises a threaded portion.
 15. The valve holder of claim 14, whereinthe valve holder comprises an opening in which the threaded portion isformed, and wherein the opening further includes an unthreaded portion,such that when the handle is inserted into the opening, a tip of thehandle passes through the unthreaded portion before reaching thethreaded portion.
 16. A system comprising the valve holder of claim 1and the prosthetic heart valve, wherein the activator is connectable tothe rotor at the top surface of the body, and wherein the prostheticheart valve is coupled to the bottom surface of the body.
 17. A valveholder for holding and implanting a prosthetic heart valve comprising aframe and a plurality of flexible leaflets, the valve holder comprising:a body for holding the prosthetic heart valve, the body having a topsurface, a bottom surface, and a central axis extending between the topand bottom surfaces; a rotor positioned in the body, the rotor rotatablearound the central axis of the body to adjust the prosthetic heart valveto a delivery position; and an activator separable from and connectableto the rotor for rotating the rotor around the central axis of the body,the activator comprising a key; wherein a stop limits the rotation ofthe activator to less than one full turn around the central axis of thebody, and wherein a keyway having a shape corresponding to a shape ofthe key on the activator permits the key to pass therethrough whendisconnecting the activator from the rotor, and wherein when theactivator is connected to the rotor, a removable handle for implantingthe prosthetic heart valve is prevented from connecting to the valveholder.
 18. The valve holder of claim 17, wherein an engagement portionis configured to engage the removable handle with the valve holder forimplanting the prosthetic heart valve, and wherein when the activator isconnected to the rotor, the activator remains disengaged from theengagement portion while preventing the removable handle from engagingwith the engagement portion and connecting with the valve holder. 19.The valve holder of claim 17, wherein the activator is onlydisconnectable from the rotor when the key is rotationally aligned withthe keyway.
 20. The valve holder of claim 17, wherein the rotor isrotatable around the central axis of the body in a first direction andnot rotatable in a second direction opposite the first direction, andwherein when the key of the activator is aligned with the keyway, theactivator is prevented from rotating in the first direction.